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NCT03755791Active, not recruitingPhase 3

Study of Cabozantinib in Combination With Atezolizumab Versus Sorafenib in Participants With Advanced Hepatocellular Carcinoma (HCC) Who Have Not Received Previous Systemic Anticancer Therapy

A Randomized, Controlled Phase 3 Study of Cabozantinib (XL184) in Combination With Atezolizumab Versus Sorafenib in Subjects With Advanced Hepatocellular Carcinoma Who Have Not Received Previous Systemic Anticancer Therapy

Source: ClinicalTrials.gov · Last updated 11 Dec 2025

Brief summary (registry, in English)

This Phase 3 study evaluates the safety and efficacy of cabozantinib in combination with atezolizumab versus the standard of care sorafenib in adults with advanced hepatocellular carcinoma (HCC) who have not received previous systemic anticancer therapy. A single-agent cabozantinib arm will be enrolled in which participants receive single agent cabozantinib in order to determine its contribution to the overall safety and efficacy of the combination with atezolizumab.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
837 (actual)
First submitted
26 Nov 2018
Start date
10 Jun 2018
Primary completion date
30 Nov 2021
Lead sponsor
Exelixis
NCT number
NCT03755791
EU CT number
2024-516479-34-00
EudraCT number
2018-003354-24

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 837
  • From 10 Jun 2018 to the primary completion date, 30 Nov 2021
  • 213 sites in 34 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior systemic anticancer therapy for advanced HCC including but not limited to chemotherapy, small molecule kinase inhibitors, and immune checkpoint inhibitors (ICIs). Participants who have received local intratumoral or arterial chemotherapy are eligible; local anticancer therapy within ≥ 28 days before randomization
  • Radiation therapy for bone metastasis within 2 weeks, any other radiation therapy within 8 weeks prior to randomization.
  • Known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 8 weeks prior to randomization.
  • Concomitant anticoagulation with oral anticoagulants
    • Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Other

  • Known fibrolamellar carcinoma, sarcomatoid HCC or mixed hepatocellular cholangiocarcinoma.

Who the study is looking for

  • Histological or cytological diagnosis of HCC or clinical diagnosis of HCC in cirrhotic patients by Computed Tomography (CT) or Computed Tomography (MRI) per the American Association for the Study of Liver Diseases (AASLD) 2018 or European Association for the Study of the Liver (EASL) 2018 guidelines.
  • The participant has disease that is not amenable to a curative treatment approach (eg, transplant, surgery, ablation therapy) or locoregional therapy (eg, TACE).
  • Measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 as determined by the Investigator.
  • Barcelona Clinic Liver Cancer (BCLC) stage Category B or C.
  • Child-Pugh Score of A.
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (213)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Exelixis Clinical Site #217
Coordinator of this site? Confirm its status
City of Buenos AiresArgentinaUnknown status
Exelixis Clinical Site #216
Coordinator of this site? Confirm its status
City of Buenos AiresArgentinaUnknown status
Exelixis Clinical Site #213
Coordinator of this site? Confirm its status
City of Buenos AiresArgentinaUnknown status
Exelixis Clinical Site #219
Coordinator of this site? Confirm its status
PilarArgentinaUnknown status
Exelixis Clinical Site #220
Coordinator of this site? Confirm its status
RosarioArgentinaUnknown status
Exelixis Clinical Site #201
Coordinator of this site? Confirm its status
RosarioArgentinaUnknown status
Exelixis Clinical Site #198
Coordinator of this site? Confirm its status
GrazAustriaUnknown status
Exelixis Clinical Site #150
Coordinator of this site? Confirm its status
KlagenfurtAustriaUnknown status
Exelixis Clinical Site #64
Coordinator of this site? Confirm its status
LinzAustriaUnknown status
Exelixis Clinical Site #137
Coordinator of this site? Confirm its status
Sankt PöltenAustriaUnknown status
Exelixis Clinical Site #174
Coordinator of this site? Confirm its status
ViennaAustriaUnknown status
Exelixis Clinical Site #107
Coordinator of this site? Confirm its status
Box HillAustraliaUnknown status
Exelixis Clinical Site #78
Coordinator of this site? Confirm its status
CamperdownAustraliaUnknown status
Exelixis Clinical Site #165
Coordinator of this site? Confirm its status
DarlinghurstAustraliaUnknown status
Exelixis Clinical Site #142
Coordinator of this site? Confirm its status
GreenslopesAustraliaUnknown status
Exelixis Clinical Site #166
Coordinator of this site? Confirm its status
HeidelbergAustraliaUnknown status
Exelixis Clinical Site #171
Coordinator of this site? Confirm its status
KingswoodAustraliaUnknown status
Exelixis Clinical Site #126
Coordinator of this site? Confirm its status
KogarahAustraliaUnknown status
Exelixis Clinical Site #17
Coordinator of this site? Confirm its status
Kurralta ParkAustraliaUnknown status
Exelixis Clinical Site #190
Coordinator of this site? Confirm its status
NedlandsAustraliaUnknown status
Exelixis Clinical Site #72
Coordinator of this site? Confirm its status
ParkvilleAustraliaUnknown status
Exelixis Clinical Site #155
Coordinator of this site? Confirm its status
WestmeadAustraliaUnknown status
Centre Hospitalier Universitaire de Liège
Coordinator of this site? Confirm its status
LiègeBelgiumCompleted
Exelixis Clinical Site #175
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BarretosBrazilUnknown status
Exelixis Clinical Site #89
Coordinator of this site? Confirm its status
Belo HorizonteBrazilUnknown status
Exelixis Clinical Site #98
Coordinator of this site? Confirm its status
Belo HorizonteBrazilUnknown status
Exelixis Clinical Site #113
Coordinator of this site? Confirm its status
CuritibaBrazilUnknown status
Exelixis Clinical Site #121
Coordinator of this site? Confirm its status
JaúBrazilUnknown status
Exelixis Clinical Site #203
Coordinator of this site? Confirm its status
Porto AlegreBrazilUnknown status
Exelixis Clinical Site #184
Coordinator of this site? Confirm its status
SalvadorBrazilUnknown status
Exelixis Clinical Site #186
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
Exelixis Clinical Site #181
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
Exelixis Clinical Site #91
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
Exelixis Clinical Site #156
Coordinator of this site? Confirm its status
São PauloBrazilUnknown status
Exelixis Clinical Site #187
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São PauloBrazilUnknown status
Exelixis Clinical Site #71
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status
Exelixis Clinical Site #205
Coordinator of this site? Confirm its status
EdmontonCanadaUnknown status
Exelixis Clinical Site #222
Coordinator of this site? Confirm its status
HalifaxCanadaUnknown status
Exelixis Clinical Site #194
Coordinator of this site? Confirm its status
HamiltonCanadaUnknown status
Exelixis Clinical Site #85
Coordinator of this site? Confirm its status
MontrealCanadaUnknown status
Exelixis Clinical Site #212
Coordinator of this site? Confirm its status
OttawaCanadaUnknown status
Exelixis Clinical Site #34
Coordinator of this site? Confirm its status
WinnipegCanadaUnknown status
Exelixis Clinical Site #115
Coordinator of this site? Confirm its status
BaselSwitzerlandUnknown status
Exelixis Clinical Site #172
Coordinator of this site? Confirm its status
BernSwitzerlandUnknown status
Exelixis Clinical Site #110
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Sankt GallenSwitzerlandUnknown status
Exelixis Clinical Site #61
Coordinator of this site? Confirm its status
ZurichSwitzerlandUnknown status
Exelixis Site #239
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Exelixis Clinical Site #237
Coordinator of this site? Confirm its status
BeijingChinaUnknown status
Exelixis Clinical Site #229
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status
Exelixis Clinical Site #246
Coordinator of this site? Confirm its status
ChangchunChinaUnknown status
Exelixis Clinical Site #231
Coordinator of this site? Confirm its status
ChangshaChinaUnknown status
Exelixis Site #241
Coordinator of this site? Confirm its status
ChangshaChinaUnknown status
Exelixis Clinical Site #224
Coordinator of this site? Confirm its status
ChangshaChinaUnknown status
Exelixis Clinical Site #235
Coordinator of this site? Confirm its status
ChengduChinaUnknown status
Exelixis Clinical Site #228
Coordinator of this site? Confirm its status
FuzhouChinaUnknown status
Exelixis Clinical Site #242
Coordinator of this site? Confirm its status
GuangzhouChinaUnknown status
Exelixis Clinical Site #223
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Exelixis Clinical Site #218
Coordinator of this site? Confirm its status
HangzhouChinaUnknown status
Exelixis Clinical Site #227
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HarbinChinaUnknown status
Exelixis Clinical Site #233
Coordinator of this site? Confirm its status
HefeiChinaUnknown status
Exelixis Clinical Site #234
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JiangyinChinaUnknown status
Exelixis Clinical Site #226
Coordinator of this site? Confirm its status
LinyiChinaUnknown status
Exelixis Clinical Site #221
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NanchangChinaUnknown status
Exelixis Clinical Site #238
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NanchangChinaUnknown status
Exelixis Clinical Site #185
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NanjingChinaUnknown status
Exelixis Site #240
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Exelixis Clinical Site #232
Coordinator of this site? Confirm its status
ShanghaiChinaUnknown status
Exelixis Clinical Site #236
Coordinator of this site? Confirm its status
ShenyangChinaUnknown status
Exelixis Clinical Site #225
Coordinator of this site? Confirm its status
XiamenChinaUnknown status
Exelixis Clinical Site #230
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ZhengzhouChinaUnknown status
Exelixis Clinical Site #130
Coordinator of this site? Confirm its status
MonteríaColombiaUnknown status
Exelixis Clinical Site #18
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Hradec KrálovéCzechiaUnknown status
Exelixis Clinical Site #37
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OlomoucCzechiaUnknown status
Exelixis Clinical Site #38
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PragueCzechiaUnknown status
Exelixis Clinical Site #10
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PragueCzechiaUnknown status
Exelixis Clinical Site #214
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BerlinGermanyUnknown status
Exelixis Clinical Site #244
Coordinator of this site? Confirm its status
Frankfurt am MainGermanyUnknown status
Exelixis Clinical Site #215
Coordinator of this site? Confirm its status
HamburgGermanyUnknown status
Exelixis Clinical Site #210
Coordinator of this site? Confirm its status
KasselGermanyUnknown status
Institut Catala D'oncologia
Coordinator of this site? Confirm its status
L'Hospitalet de LlobregatSpainCompleted
Hospital Universitario Puerta de Hierro de Majadahonda
Coordinator of this site? Confirm its status
MajadahondaSpainCompleted
CHRU De Nancy
Coordinator of this site? Confirm its status
Vandoeuvre Les NancyFranceActive, not recruiting
Exelixis Clinical Site #196
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BelfastUnited KingdomUnknown status
Exelixis Clinical Site #83
Coordinator of this site? Confirm its status
BristolUnited KingdomUnknown status
Exelixis Clinical Site #87
Coordinator of this site? Confirm its status
CambridgeUnited KingdomUnknown status
Exelixis Clinical Site #151
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Exelixis Clinical Site #129
Coordinator of this site? Confirm its status
LondonUnited KingdomUnknown status
Exelixis Clinical Site #192
Coordinator of this site? Confirm its status
ManchesterUnited KingdomUnknown status
Exelixis Clinical Site #69
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BatumiGeorgiaUnknown status
Exelixis Clinical Site #68
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TbilisiGeorgiaUnknown status
Exelixis Clinical Site #70
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TbilisiGeorgiaUnknown status
Exelixis Clinical Site #67
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TbilisiGeorgiaUnknown status
Exelixis Clinical Site #66
Coordinator of this site? Confirm its status
TbilisiGeorgiaUnknown status
Exelixis Clinical Site #146
Coordinator of this site? Confirm its status
Hong KongHong Kong SAR ChinaUnknown status
Exelixis Clinical Site #9
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Hong KongHong Kong SAR ChinaUnknown status
Exelixis Clinical Site #42
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Hong KongHong Kong SAR ChinaUnknown status
University of Debrecen
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DebrecenHungaryCompleted
Exelixis Clinical Site #170
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DublinIrelandUnknown status
Exelixis Clinical Site #30
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JerusalemIsraelUnknown status
Exelixis Clinical Site #33
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Petah TikvaIsraelUnknown status
Exelixis Clinical Site #40
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Ramat GanIsraelUnknown status
Exelixis Clinical Site #35
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RehovotIsraelUnknown status
Exelixis Clinical Site #158
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BolognaItalyUnknown status
Exelixis Clinical Site #152
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BresciaItalyUnknown status
Exelixis Clinical Site #147
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MilanItalyUnknown status
Exelixis Clinical Site #149
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NaplesItalyUnknown status
Exelixis Clinical Site #131
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NovaraItalyUnknown status
Exelixis Clinical Site #167
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RomaItalyUnknown status
Exelixis Clinical Site #53
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RozzanoItalyUnknown status
Exelixis Clinical Site #182
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TorinoItalyUnknown status
Exelixis Clinical Site #177
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TorinoItalyUnknown status
Exelixis Clinical Site #163
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TricaseItalyUnknown status
Exelixis Clinical Site #243
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UdineItalyUnknown status
Exelixis Clinical Site #114
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BusanSouth KoreaUnknown status
Exelixis Clinical Site #86
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BusanSouth KoreaUnknown status
Exelixis Clinical Site #77
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BusanSouth KoreaUnknown status
Exelixis Clinical Site #157
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Goyang-siSouth KoreaUnknown status
Exelixis Clinical Site #75
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IncheonSouth KoreaUnknown status
Exelixis Clinical Site #99
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SeoulSouth KoreaUnknown status
Exelixis Clinical Site #104
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SeoulSouth KoreaUnknown status
Exelixis Clinical Site #105
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SeoulSouth KoreaUnknown status
Exelixis Clinical Site #79
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SeoulSouth KoreaUnknown status
Exelixis Clinical Site #93
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SeoulSouth KoreaUnknown status
Exelixis Clinical Site #127
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SuwonSouth KoreaUnknown status
Exelixis Clinical Site #135
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LeónMexicoUnknown status
Exelixis Clinical Site #133
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Mexico CityMexicoUnknown status
Exelixis Clinical Site #160
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Mexico CityMexicoUnknown status
Exelixis Clinical Site #132
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MonterreyMexicoUnknown status
Exelixis Clinical Site #134
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San Luis Potosí CityMexicoUnknown status
Exelixis Clinical Site #141
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Tuxtla GutiérrezMexicoUnknown status
Exelixis Clinical Site #153
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VeracruzMexicoUnknown status
Exelixis Clinical Site #52
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AmsterdamNetherlandsUnknown status
Exelixis Clinical Site #92
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MaastrichtNetherlandsUnknown status
Exelixis Clinical Site #84
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RotterdamNetherlandsUnknown status
Exelixis Clinical Site #36
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UtrechtNetherlandsUnknown status
Exelixis Clinical Site #60
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GraftonNew ZealandUnknown status
Exelixis Clinical Site #62
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NewtonNew ZealandUnknown status
Exelixis Clinical Site #118
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Cebu CityPhilippinesUnknown status
Exelixis Clinical Site #117
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PasigPhilippinesUnknown status
Exelixis Clinical Site #136
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Quezon CityPhilippinesUnknown status
Exelixis Clinical Site #24
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GdanskPolandUnknown status
Exelixis Clinical Site #15
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MysłowicePolandUnknown status
Exelixis Clinical Site #41
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WarsawPolandUnknown status
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca
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Cluj-NapocaRomaniaActive, not recruiting
Exelixis Clinical Site #81
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KalugaRussiaUnknown status
Exelixis Clinical Site #74
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KislinoRussiaUnknown status
Exelixis Clinical Site #95
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KrasnodarRussiaUnknown status
Exelixis Clinical Site #108
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MoscowRussiaUnknown status
Exelixis Clinical Site #101
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MurmanskRussiaUnknown status
Exelixis Clinical Site #80
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Nizhny NovgorodRussiaUnknown status
Exelixis Clinical Site #90
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Saint PetersburgRussiaUnknown status
Exelixis Clinical Site #111
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Saint PetersburgRussiaUnknown status
Exelixis Clinical Site #73
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SochiRussiaUnknown status
Exelixis Clinical Site #97
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SingaporeSingaporeUnknown status
Exelixis Clinical Site #116
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SingaporeSingaporeUnknown status
Exelixis Clinical Site #106
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SingaporeSingaporeUnknown status
Exelixis Clinical Site #143
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Chiang MaiThailandUnknown status
Exelixis Clinical Site #139
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Hat YaiThailandUnknown status
Exelixis Clinical Site #183
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Khon KaenThailandUnknown status
Exelixis Clinical Site #96
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Pathum WanThailandUnknown status
Exelixis Clinical Site #119
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ChanghuaTaiwanUnknown status
Exelixis Clinical Site #162
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Kaohsiung CityTaiwanUnknown status
Exelixis Clinical Site #161
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TaichungTaiwanUnknown status
Exelixis Clinical Site #197
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TainanTaiwanUnknown status
Exelixis Clinical Site #145
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TainanTaiwanUnknown status
Exelixis Clinical Site #82
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TaipeiTaiwanUnknown status
Exelixisi Clinical Site #100
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TaipeiTaiwanUnknown status
Exelixis Clinical Site #128
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TaipeiTaiwanUnknown status
Exelixis Clinical Site #94
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TaoyuanTaiwanUnknown status
Exelixis Clinical Site #125
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ChernivtsiUkraineUnknown status
Exelixis Clinical Site #122
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DniproUkraineUnknown status
Exelixis Clinical Site #123
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KharkivUkraineUnknown status
Exelixis Clinical Site #124
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OdesaUkraineUnknown status
Exelixis Clinical Site #138
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UzhhorodUkraineUnknown status
Exelixis Clinical Site #76
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AlbuquerqueUnited StatesUnknown status
Exelixis Clinical Site #4
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AtlantaUnited StatesUnknown status
Exelixis Clinical Site #6
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BaltimoreUnited StatesUnknown status
Exelixis Clinical Site #7
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BurlingtonUnited StatesUnknown status
Exelixis Clinical Site #12
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Chapel HillUnited StatesUnknown status
Exelixis Clinical Site #144
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CharlestonUnited StatesUnknown status
Exelixis Clinical Site #195
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ChicagoUnited StatesUnknown status
Exelixis Clinical Site #120
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ChicagoUnited StatesUnknown status
Exelixis Clinical Site #199
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DallasUnited StatesUnknown status
Exelixis Clinical Site #154
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HoustonUnited StatesUnknown status
Exelixis Clinical Site #5
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Kansas CityUnited StatesUnknown status
Exelixis Clinical Site #11
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Kansas CityUnited StatesUnknown status
Exelixis Clinical Site #44
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La JollaUnited StatesUnknown status
Exelixis Clinical Site #1
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Las VegasUnited StatesUnknown status
Exelixis Clinical Site #112
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Los AngelesUnited StatesUnknown status
Exelixis Clinical Site #191
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MiamiUnited StatesUnknown status
Exelixis Clinical Site #14
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New BrunswickUnited StatesUnknown status
Exelixis Clinical Site #200
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OrangeUnited StatesUnknown status
Exelixis Clinical Site #88
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PhiladelphiaUnited StatesUnknown status
Exelixis Clinical Site #208
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PhoenixUnited StatesUnknown status
Exelixis Clinical Site #176
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PortlandUnited StatesUnknown status
Exelixis Clinical Site #2
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RialtoUnited StatesUnknown status
Exelixis Clinical Site #207
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San DiegoUnited StatesUnknown status
Exelixis Clinical Site #54
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San FranciscoUnited StatesUnknown status
Exelixis Clinical Site #109
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San FranciscoUnited StatesUnknown status
Exelixis Clinical Site #13
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SeattleUnited StatesUnknown status
Exelixis Clinical Site #46
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SeattleUnited StatesUnknown status
Exelixis Clinical Site #3
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SpokaneUnited StatesUnknown status
Exelixis Clinical Site #8
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St LouisUnited StatesUnknown status
Exelixis Clinical Site #19
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TempleUnited StatesUnknown status
Exelixis Clinical Site #39
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ToledoUnited StatesUnknown status
Exelixis Clinical Site #159
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TucsonUnited StatesUnknown status
Exelixis Clinical Site #58
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Washington D.C.United StatesUnknown status
Exelixis Clinical Site #193
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AnkaraTurkey (Türkiye)Unknown status
Exelixis Clinical Site #178
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AnkaraTurkey (Türkiye)Unknown status
Exelixis Clinical Site #173
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EdirneTurkey (Türkiye)Unknown status
Exelixis Clinical Site #189
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IstanbulTurkey (Türkiye)Unknown status
Exelixis Clinical Site #179
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IstanbulTurkey (Türkiye)Unknown status
Exelixis Clinical Site #180
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MalatyaTurkey (Türkiye)Unknown status

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